MULTISKAN (78-503-00)

Colorimeter, Photometer, Spectrophotometer For Clinical Use

FLOW LABORATORIES, INC.

The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Multiskan (78-503-00).

Pre-market Notification Details

Device IDK790422
510k NumberK790422
Device Name:MULTISKAN (78-503-00)
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-28
Decision Date1979-04-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.